Identity
- Trade Name
- Biodesign FDA UDI
- Generic Name
- ENT tissue biomatrix implant FDA UDI
- Device Name
- Biodesign Otologic Butterfly Graft FDA UDI
- Model / Reference
- G60285 FDA UDI
- Description
- Biodesign Otologic Butterfly Graft FDA UDI
Identifiers
- Catalog Number
- ENT-OTO-BFLY-0.4-0.6 FDA UDI
- Primary DI / UDI-DI
- 00827002602854 FDA UDI
- 510(k) Number
- K232646 FDA UDI
- FDA Product Code
- KHJ FDA UDI
- GMDN Term
- ENT tissue biomatrix implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: ENT tissue biomatrix implant
Biodesign by Cook Biotech Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Biotech Incorporated
Sources (1)
- FDA UDI 0106ccbc-8f33-4a0a-8eaf-b651b7e02984 37 fields · synced May 30, 2026